MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIMA BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00539220
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was used during an endoscopic retrograde cholangiopancreatography in the common bile duct, performed on (b)(6) 2021.During the procedure, when the physician attempted to pull back the guide catheter to position the stent, the guide catheter was ripped off.Reportedly, the broken guide catheter remained within the push catheter enabling the device to be removed in one piece.The procedure was successfully completed with another flexima biliary stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.The device has not been received for analysis.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was used during an endoscopic retrograde cholangiopancreatography in the common bile duct, performed on (b)(6) 2021.During the procedure, when the physician attempted to pull back the guide catheter to position the stent, the guide catheter was ripped off.Reportedly, the broken guide catheter remained within the push catheter enabling the device to be removed in one piece.The procedure was successfully completed with another flexima biliary stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.
Additional Manufacturer Narrative
Block h6: medical device code a0401 captures the reportable event of guide catheter broken.Block h10: a flexima bili preloaded stent returned for analysis without the stent.A visual evaluation noted that the guide catheter was kinked, stretched and detached.Also, the push catheter was kinked at the distal section.Additionally, under magnification, it was possible to observe that the push suture hole wastorn.No other issues with the device were noted.The reported event was confirmed.Upon analysis, the guide catheter kinked, stretched and detached; also, the push catheter was kink and the push suture hole was torn.The push catheter could be kinked by the manipulation of the device during advancing into the scope causing resistance shown by the push suture hole when the guide catheter was pulled back to position the stent, and as a result of damaging the guide catheter.There, the most probable cause of the reported event is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

• Brand Name: FLEXIMA BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11354374
• Report Number: 3005099803-2021-00587
• Device Sequence Number: 14288792
• Product Code: FGE
• UDI-Device Identifier: 08714729162537
• UDI-Public: 08714729162537
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K965147
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/06/2022
• Device Model Number: M00539220
• Device Catalogue Number: 3922
• Device Lot Number: 0024551798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1